Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

NCT04240171 | Completed DMC

• 1 other identifier: Dapagliflozin in T2DM
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Research objectives: The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe), NT-Pro BNP and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Blood Sugar (mg/dl)

  serum blood glucose

  three months

• HbA1c %

  Glycated Hemoglobin

  three months

Secondary Outcomes (3)

• NT-Pro BNP (ng/ml)

  Three Months

• IRAPe (ng/ml)

  Three Months

• IL-34 (pg./ml)

  Three Months

Study Arms (2)

dapagliflozin

Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level.

Drug: Dapagliflozin 5Mg Tab

glimepiride

Group 2 (n=30): are the patients who are prescribed glimepiride

Drug: Glimepiride 4Mg Tab

Interventions

Dapagliflozin 5Mg Tab DRUG

Dapagliflozin 5mg tablets daily

Also known as: Diglifloz

dapagliflozin

Glimepiride 4Mg Tab DRUG

Glimepiride Tablets daily

Also known as: Amaryl

glimepiride

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3- 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital. 4- Serum samples will be collected for measuring the biomarkers. All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Group 2 (n=30): are the patients who are prescribed glimepiride * All patients will be followed up during 3 months' period. * At the end of 3 months, step 4 will be repeated.

You may qualify if:

• Patients with type 2 DM diagnosed clinically. The age ranged from 18 to 70 years. There are no limits to the duration of DM and gender.
• HbA1c ≥ 7

You may not qualify if:

• Other types of DM
• Hypersensitivity to the drug
• Abnormal liver function
• Patients with renal impairment (eGFR ≤ 60 ml/min)
• Previous history of bladder cancer

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (4)

• Monami M, Nardini C, Mannucci E. Efficacy and safety of sodium glucose co-transport-2 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2014 May;16(5):457-66. doi: 10.1111/dom.12244. Epub 2013 Dec 29.

  PMID: 24320621 RESULT

• Abdul-Ghani MA, Norton L, DeFronzo RA. Renal sodium-glucose cotransporter inhibition in the management of type 2 diabetes mellitus. Am J Physiol Renal Physiol. 2015 Dec 1;309(11):F889-900. doi: 10.1152/ajprenal.00267.2015. Epub 2015 Sep 9.

  PMID: 26354881 RESULT

• Davidson JA, Kuritzky L. Sodium glucose co-transporter 2 inhibitors and their mechanism for improving glycemia in patients with type 2 diabetes. Postgrad Med. 2014 Oct;126(6):33-48. doi: 10.3810/pgm.2014.10.2819.

  PMID: 25414933 RESULT

• Zekry R, Omran GA, El-Gharbawy NM, Werida RH. Comparative study of Dapagliflozin versus Glimepiride effect on insulin regulated aminopeptidase (IRAP) and interleukin-34 (IL-34) in patient with type 2 diabetes mellitus. Sci Rep. 2023 Apr 18;13(1):6302. doi: 10.1038/s41598-023-33417-3.

  PMID: 37072577 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nashwa EL-Gharabawy, Lecturer

  Tanta University

  STUDY CHAIR

• Rehab Werida

  Damanhour University, Faculty of Pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Lecturer

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: January 27, 2020
• Study Start: December 1, 2020
• Primary Completion: January 30, 2022
• Study Completion: January 31, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)